Sonlicromanol for post-COVID fatigue with post-exertional malaise.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled phase II trial comparing sonlicromanol to placebo in people with post-COVID who experience post-exertional malaise. Eligible participants meet WHO post-COVID criteria, have PEM by the DSQ-PEM questionnaire, and have a Bell disability score between 20% and 70%, with no prior hospitalization for their acute COVID infection. Participants are randomly assigned to receive sonlicromanol or placebo and outcomes are measured using patient-reported fatigue and PEM instruments and functional disability measures. The trial is led at Amsterdam University Medical Center in the Netherlands and sponsored in collaboration with ZonMw and Khondrion BV.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Post COVID according to WHO criteria and verified by post COVID physician
* Post-exertional malaise (PEM) according to DSQ-PEM questionnaire
* Bell's disability score 20-70%
* Mild initial SARS-CoV-2 infection (no hospitalisation)
* WHO performance score of 0 before initial SARS-CoV-2 infection

Exclusion Criteria:

* Patients at risk for cardiac conduction disorders
* History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP
* Clinically significant respiratory or cardiovascular disease
* Unstable neurological disease
* Clinically significant active psychiatric disorder that requires treatment
* History of substance abuse
* Active malignancy within the past 5 years
* History of solid organ transplantation
* Active HIV, hepatitis B or C infection
* BMI \< 18.5 or \> 35
* Pregnancy or breastfeeding
* Clinically relevant laboratory test value outside the reference range
* Use of the following medication, unless stable for at least one month before study and remaining stable throughout the study: (multi)vitamins, co-enzyme Q10, Vitamin E, riboflavin, amino acids, antioxidant supplements and any medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, antivirals, amiodarone and NSAIDs)
* Use of the following medication: any moderate or strong Cytochrome P450 (CYP)3A4 inhibitors (all 'conazoles-anti-fungals', HIV antivirals, grapefruit), strong CYP3A4 inducers ((including HIV antivirals, carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort, pioglitazone, troglitazone) or any medication metabolized by CYP3A4 with a narrow therapeutic index, medication known to be substrate of Organic Cation Transporter 1 (OCT1) and organic cation transporter 2 (OCT2) or strong P-glycoprotein inhibitors (including amiodarone, azithromycin, captopril, clarithromycin, cyclosporine, piperine, quercetin, quinidine, quinine, reserpine, ritonavir, tariquidar, and verapamil).
* Use of any medication known to affect cardiac repolarization unless QTc interval at screening is normal during stable treatment for a period of two weeks, or 5 half-lives

Where it's running

• Amsterdam University Medical Center, Location Academic Medical Center (AMC)
  Amsterdam, North Holland, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.